(NAR) VOL. 29 NO. 2/ APRIL - JUNE 18
A. Bureau of Customs (BOC) is the national agency under the Department of
Finance in charge of imports, exports, and foreign trade.
B. Center for Device Regulation, Radiation Health, and Research (CDRRHR) is the national agency under the Food and Drug Administration of the Department of Health that regulates the production, import, export, distribution, sale, promotion, and use of electrical/electronic devices capable of emitting radiation. Its former name is the Bureau of Health Devices and Technology.
C. Clearance for Customs Release (CFCR) refers to a document issued upon approval of the CDRRHR allowing and informing the release of regulated imports by the BOC.
D. Certificate of Product Registration is an authorization issued to an approved application for a device registration.
E. Device means medical devices and radiation devices.1. Medical Device shall mean any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent and calibrator, software, material or other similar or related article intended by the product owner to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of disease; diagnosis, monitoring, treatment, alleviation of or compensation for an injury; investigation, replacement, modification, or support of the anatomy or of a physiological process; supporting or sustaining life; control of conception; disinfection of medical devices; and providing information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body. This device does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means.
2. Radiation Device means an electrical or electronic apparatus emitting any ionizing or non-ionizing electromagnetic or particulate radiation; or any sonic, infrasonic, or ultrasonic wave. It includes ionizing radiation emitting device which is not intentionally designed to produce radioactive materials.
F. Device Accessories are parts of a device intended to supplement, support or augment the performance of radiation device for a useful purpose, but such parts are not designed by it to produce radiation.
G. Importer refers to any person or establishment that imports devices for its own use or for distribution to other establishments.V. SPECIFIC GUIDELINES
H. Non-emitting Radiation Devices are devices not capable of producing radiation.
A. The client shall submit a written request for issuance of a CFCR addressed to the Director of the CDRRHR containing the following information and documents:
1. Number of units to be imported;
2. Intended use of unit;
3. Name and address of importer/supplier;
4. Name of owner and address of the facility where the unit will be installed
(if available);
5. A duly notarized letter guaranteeing submission to the CDRRHR of the name and address of the buyer of the device within fifteen (15) days of the sale/transfer of ownership of the device (if name of buyer is unavailable upon application);
6. For a radiation device item to be used for medical applications, a Certificate of Product Registration (CPR) or any equivalent document certifying that the product is safe and allowed to be sold in the country of origin issued by the Ministry of Health of the country of origin;a. This document shall be duly authenticated by the Philippine7. For a radiation device item to be used for non-medical applications, a document certifying that the product is safe and allowed to be sold in the country of origin issued by the Ministry of Health of the country of origin, or international certification for safety for a particular device (i.e., standards issued by the International Electrotechnical Commission);
Consulate in the country of origin.
b. If the CPR is unavailable immediately, a duly notarized letter guaranteeing submission of this document to the CDRRHR, within sixty (60) days from receipt by the CDRRHR of the written request, shall be allowed in lieu of the CPR.a. This document shall be duly authenticated by the Philippine8. Brochure/Literature of the device/device;
Consulate in the country of origin.
b. A duly notarized letter guaranteeing submission of this document to the CDRRHR, within sixty (60) days from receipt by the CDRRHR of the written request, shall be allowed.
9. Copy of importer’s permit (from the local government where the office of the importer is located); and
10. Copy of proforma invoice.
B. Upon submission of all the requirements, an evaluation within three (3) working days shall be done by the CDRRHR - Radiation Regulation Division to determine whether the device is capable of emitting radiation or not. If the device is radiation-emitting, a CFCR shall be required.
C. Pursuant to Customs Memorandum Order No. 9-2015 dated 10 April 2015 entitled “On the Strict Enforcement of Rules Concerning Regulated Imports”, all importers shall be required to provide a CFCR for radiation devices listed below when filing import entries with the BOC:
1. Radiation Devices used for Medical ApplicationsVI. FEES AND PAYMENTa) Computed Tomography (CT) Dental X-ray Machine b) Conventional X-ray Machine2. Radiation Devices used for Non-Medical Applications
c) Dental Conventional X-ray Machine
d) Dental panoramic X-ray Machine
e) Dental Radiography X-ray Machine f) Electron Microscope
g) Laser Pointer (Laser for Medical, Ophthalmology & Dental Purpose)
h) Linear Accelerator
i) Mammography X-ray Machine j) Medical CT X-ray Machine
k) Mobile X-ray Machine
l) Portable X-ray Machine
m) Transportable X-ray Machine n) Tomotherapy Machine
o) UV/Laser (for Dermatology)a) Anti-Crime X-ray MachineD. Radiation devices listed below are also regulated imports and are required to have a CFCR from the CDRRHR:
b) Cabinet Type X-ray Machine c) Industrial X-ray Machine
d) Laser Device
e) X-ray Diffractometer
f) X-ray Fluorescence Analyzer
1. Radiation Devices used for Medical Applications
a) Magnetic Resonance Imaging (MRI)
b) Ultrasound Machine c) Bone Densitometer
d) Interventional X-ray Machine
2. Radiation Devices used for Non-Medical Applications
a) X-ray Machines used in:1) Research X-ray Facilityb) Laser
2) Veterinary X-ray Facility
3) Education and Training X-ray Facility
c) UV
d) Infrared
E. RF coils for MRI, ultrasound probes or transducers, X-ray tubes (and other parts or device accessories used for replacement of x-ray tube) are required to have a CFCR from the CDRRHR prior to release of the said regulated imports. However, radiation device parts and device accessories such as cassettes, printers, software, and/or of the same kind shall not be required to have a CFCR from the CDRRHR.
F. For medical devices listed in the FDA Memorandum Circular No. 2014-005 and its amendments, a CPR is required prior to release by the BOC. For exempted products, a Certificate of Exemption shall be required.